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Effect of PulmozymeÂ® Withdrawal on Exercise Tolerance in People with Cystic Fibrosis

Study Type:

Interventional

Intervention Category:

Mucus Alteration

Study Sponsor:

Genentech

Study Phase:

4

Recruitment Status:

Trial Completed

Study Drug(s):

Pulmozyme

Number of Participants Being Recruited:

100

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

This study looks at the ability to do exercise, pulmonary function tests and other effects in people with CF when PulmozymeÂ® is withdrawn for 2 weeks. PulmozymeÂ® is an approved drug that thins mucus in the lungs of people with CF, making it easier to cough out the mucus. People whose CF symptoms are stable for 2 weeks prior to joining the trial will be able to participate. The study will last at most 35 days with four study visits. The exercise will be a 6-minute walk test on a flat surface. Outcome measures will also be pulmonary function; patient-reported health-related quality of life questions (HRQOL); and other measures.

ELIGIBILITY

Age:

>= 14 Years

FEV1:

Not Applicable

P. aeruginosa status:

Not applicable

B. cepacia status:

Not applicable

Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.

The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.